A Phase 1 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) in Patients With Locally Advanced or Metastatic Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01375842
First received: June 16, 2011
Last updated: January 14, 2016
Last verified: January 2016
  Purpose
This Phase I, multicenter, first in human, open-label, dose escalation study will evaluate the safety, tolerability, and pharmacokinetics of Atezolizumab administered as single agent by intravenous (IV) infusion to patients with locally advanced or metastatic solid malignancies or hematologic malignancies.

Condition Intervention Phase
Solid Cancers
Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open Label, Dose Escalation Study of the Safety and Pharmacokinetics of MPDL3280A Administered Intravenously As a Single Agent to Patients With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence of dose limiting toxicities (DLTs) [ Time Frame: Up to day 21 ] [ Designated as safety issue: No ]
  • Nature of dose limiting toxicities (DLTs) [ Time Frame: Up to day 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events graded according to NCI CTCAE v4.0 [ Time Frame: Up to 90 days after the last dose of study treatment or until initiation of another anti cancer therapy, whichever occurs first ] [ Designated as safety issue: No ]
  • Nature of adverse events graded according to NCI CTCAE v4.0 [ Time Frame: Up to 90 days after the last dose of study treatment or until initiation of another anti cancer therapy, whichever occurs first ] [ Designated as safety issue: No ]
  • Severity of adverse events graded according to NCI CTCAE v4.0 [ Time Frame: Up to 90 days after the last dose of study treatment or until initiation of another anti cancer therapy, whichever occurs first ] [ Designated as safety issue: No ]

Estimated Enrollment: 604
Study Start Date: June 2011
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1
Intravenous (IV) infusion repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >/=18 years, patients who are <18 years old may be enrolled after consultation with the Medical Monitor
  • Histologically or cytologically documented, incurable or metastatic solid tumor or hematologic malignancy
  • Representative tumor specimens in paraffin blocks/unstained slides, with an associated pathology report
  • Adequate hematologic and end organ function
  • Measurable disease per RECIST for patients with solid malignancies or per protocol-specified disease-specific criteria for patients with prostate cancer, glioblastoma multiforme (GBM), malignant lymphoma, or multiple myeloma
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

  • Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases
  • History or risk of autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, etc.)
  • History of HIV, hepatitis B, or hepatitis C infection
  • Any signs or symptoms of infection
  • Malignancies other than disease under study within 5 years
  • Prior allogeneic stem cell transplant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375842

Contacts
Contact: Reference Study ID Number: PCD4989g www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
United States, Arizona
Completed
Scottsdale, Arizona, United States, 85258
United States, California
Completed
Los Angeles, California, United States, 90025
Completed
Stanford, California, United States, 94305
United States, Connecticut
Completed
New Haven, Connecticut, United States, 06520
United States, Florida
Completed
Tampa, Florida, United States, 33612-9497
United States, Illinois
Completed
Chicago, Illinois, United States, 60637
United States, Maryland
Completed
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Completed
Boston, Massachusetts, United States, 02215
Completed
Boston, Massachusetts, United States, 02114
United States, Nevada
Completed
Las Vegas, Nevada, United States, 89169
United States, New York
Completed
Albany, New York, United States, 12206
United States, North Carolina
Completed
Huntersville, North Carolina, United States, 28078
United States, Tennessee
Completed
Nashville, Tennessee, United States, 37203
Completed
Nashville, Tennessee, United States, 37232
United States, Virginia
Completed
Norfolk, Virginia, United States, 23502
France
Recruiting
Lyon, France, 69008
Recruiting
Toulouse, France, 31059
Completed
Villejuif, France, 94805
Spain
Completed
Barcelona, Spain, 08035
United Kingdom
Completed
London, United Kingdom, EC1A 7BE
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

No publications provided by Genentech, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01375842     History of Changes
Other Study ID Numbers: PCD4989g  2011-001422-23  GO27831 
Study First Received: June 16, 2011
Last Updated: January 14, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
PD-L1
PD-1
lymphoma
esophageal cancer
antiPD-L1
MPDL3280A
Solid tumor
Renal cell Carcinoma (RCC)
Melanoma (MEL)
Non-small Cell Lung Cancer (NSCLC)
Breast Cancer
Gastric Cancer
Head and Neck Cancer
Colorectal Cancer
Heme Malignancies
Non-Hodgkin Lymphoma
Multiple Myeloma
MPDL320A

ClinicalTrials.gov processed this record on February 10, 2016